NCT05215990

Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis

Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a randomized controlled trial studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin with pulmonary tuberculosis standard treatment group and placebo drug with pulmonary tuberculosis standard treatment.

Detailed description

1. Pulmonary tuberculosis Patients with presence of at least one acid-fast bacillus in the sputum will be examined by an internist. 2. Collect the necessary basic information of patients who agree to participate in the treatment such as complete blood count, blood urea nitrogen, creatinine, liver function test, fasting plasma glucose, hemoglobinA1C, lactate, and gene expression signature for tuberculosis. 3. Patients will be randomized into 2 groups: those who will receive metformin with pulmonary tuberculosis standard treatment and those who will receive placebo drug with pulmonary tuberculosis standard treatment. 4. Patients will get a chest x-ray and collect sputum acid fast bacillus, sputum culture for tuberculosis and collect blood sample laboratory such as complete blood count, liver function test, creatinine, fasting plasma glucose, lactate, and gene expression signature for tuberculosis at second week. 5. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at second month. 6. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at fifth month. 7. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at sixth month. 8. After collecting all information of patients, Investigators will analyze in clinical and statistical analysis.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	MetFORMIN 500 Mg Oral Tablet	studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive metformin with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month.
DRUG	Placebo	studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive placebo drug with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month.

Timeline

• Start date: 2022-01-15
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2022-01-31
• Last updated: 2022-02-14

Locations

1 site across 1 country: Thailand